NCT06821724

Brief Summary

One hundred children with white spot lesions on their teeth were divivided into 5 groups of different remineralizing agents to assess their effect on color change and remineralization

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2025

Completed
17 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2025

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

February 6, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 12, 2025

Completed
Last Updated

February 12, 2025

Status Verified

February 1, 2025

Enrollment Period

2 months

First QC Date

February 6, 2025

Last Update Submit

February 6, 2025

Conditions

White Spot Lesion of Tooth

Keywords

White spotsRemineralizationCariesChildren

Outcome Measures

Primary Outcomes (1)

  • Assessment of color change

    Color change assessmentof white spot lesions using "Easy-shade" device

    before treatment, immediately after treatment, 2 weeks and 6 weeks after the onset of treatment

Secondary Outcomes (1)

  • Remineralization assessment

    before treatment, immediately after treatment, 2 weeks and 6 weeks after the onset of treatment

Study Arms (5)

No treatment

NO INTERVENTION

Negative control

Fluoride gel

ACTIVE COMPARATOR

Positive control

Drug: Fluoride gel

Casein phosphopeptide-amorphous calcium phosphate (CPP-ACP) (MI paste)

EXPERIMENTAL

Intervention

Drug: Casein phosphopeptide-amorphous calcium phosphate

Casein phosphopeptide-amorphous calcium phosphate (CPP-ACP) + fluoride (MI paste plus)

EXPERIMENTAL

Intervention

Drug: Casein phosphopeptide-amorphous calcium phosphate + fluoride

Nano hydroxyapatite paste (Apagard primo toothpaste)

EXPERIMENTAL

Intervention

Drug: Nano hydroxyapatite paste

Interventions

Casein phosphopeptide-amorphous calcium phosphateDRUG

Intervention

Also known as: (CPP-ACP) (MI paste)
Casein phosphopeptide-amorphous calcium phosphate (CPP-ACP) (MI paste)
Casein phosphopeptide-amorphous calcium phosphate + fluorideDRUG

Intervention

Also known as: (CPP-ACP) + (MI paste plus)
Casein phosphopeptide-amorphous calcium phosphate (CPP-ACP) + fluoride (MI paste plus)
Nano hydroxyapatite pasteDRUG

Intervention

Also known as: (Apagard primo toothpaste)
Nano hydroxyapatite paste (Apagard primo toothpaste)
Fluoride gelDRUG

Positive control

Also known as: Active Comparator
Fluoride gel

Eligibility Criteria

Age10 Years - 14 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Presence of at least one tooth affected by white spot lesion.
  • Good oral hygiene and regular tooth brushing at least twice daily.

You may not qualify if:

  • Unwillingness to be randomly assigned to 1 of the 3 treatment groups.
  • Presence of abnormal oral, medical, or mental condition.
  • Presence of any milk-related allergies.
  • Presence of dentin caries or enamel hypoplasia on maxillary anterior teeth.
  • Presence of periodontal pockets around maxillary anterior teeth.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Research Centre

Dokki, Giza Governorate, 12622, Egypt

Location

Related Publications (1)

  • El Mansy MM, Rashed MF, Saleh RS. Effect of remineralization after in office followed by home treatment of white spot lesions in children randomized controlled trial. Sci Rep. 2025 Aug 19;15(1):30448. doi: 10.1038/s41598-025-15829-5.

    PMID: 40830200DERIVED

MeSH Terms

Interventions

casein phosphopeptide-amorphous calcium phosphate nanocomplexFluorides

Intervention Hierarchy (Ancestors)

AnionsIonsElectrolytesInorganic ChemicalsHydrofluoric AcidFluorine Compounds

Study Officials

  • Mohamed F Rashed, Researcher

    National Research Centre, Egypt

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Blinding to the child participants and legal guardian of each participating child, inter examiner and statistician. The operator and the child were blinded to the intervention from the beginning till teeth polishing. Blinding cannot be done during application of remineralizing agents because of clear visual differences between these agents.
Purpose
TREATMENT
Intervention Model
FACTORIAL
Model Details: Randomized controlled parallel double blinded study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Researcher of Pediatric Dentistry

Study Record Dates

First Submitted

February 6, 2025

First Posted

February 12, 2025

Study Start

December 1, 2024

Primary Completion

January 15, 2025

Study Completion

February 1, 2025

Last Updated

February 12, 2025

Record last verified: 2025-02

Locations

EG(1)